All posts tagged drug makers

Dublin-based Shire PLC, a specialist in drugs to treat attention-deficit disorder and rare diseases, has rejected a £27.2 billion ($46.35 billion) takeover bid from U.S. rival AbbVie Inc., in the latest move by a U.S. company to pursue a deal for a company with a lower tax rate.

Shire, which is tax-resident in Ireland, said in a statement Friday the proposal “fundamentally undervalued the company and its prospects.” The proposal comes amid a wave of interest in such so-called tax-inversion deals, most prominently Pfizer Inc.’s failed $120 billion attempt to buy AstraZeneca PLC, which ended last month. Similarly, U.S. medical-device company Medtronic Inc. on Sunday agreed to buy the U.K.’s Covidien PLC for $42.9 billion, also in part to lower its tax rate.

AbbVie can always come back with a fresh offer, and other suitors may emerge. But for now, Shire is staying solo. Corporate Intelligence did a selective survey of some of the other companies that have managed to stay single—at least for now—in the current scramble for trans-Atlantic deal partners. Read More »

Millions of pills go unused in household medicine cabinets – often long past expiration dates – and now some California lawmakers think drug makers should pay to get rid of them. A new bill to create a ‘take-back’ program is pending in the California legislature. If passed, the state would become the first to adopt such a measure and proponents hope the idea will gain traction elsewhere.

The move, which has drug makers on edge, reflects growing frustration among California officials worried about drinking water and contamination from medicines flushed down the toilet or drug abuse from stockpiled painkillers. They say disposal costs can overwhelm local governments, which are starting to turn to the pharmaceutical industry to underwrite these programs.

“It’s long overdue for the pharmaceutical companies to accept responsibility,” says California state senator Hannah-Beth Jackson, who introduced the bill. More on this after the jump… Read More »

New funding worth $240 million to treat neglected tropical diseases will be announced later Wednesday at a meeting of drug companies, governments and charities in Paris.

Two years ago, 13 drug companies (among them AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Novartis, Pfizer and Sanofi) signed up to a global public-private partnership to control or eradicate 10 of the most prevalent neglected tropical diseases by 2020.

The diseases being targeted include elephantiasis, trachoma, river blindness, bilharzia and Guinea worm. More than a billion people—one-sixth of the world’s population—are infected with one or more neglected tropical diseases.

After years of considerable hand wringing over the financial ties between physicians and drug makers, another set of relationships is starting to draw notice – the people who play leading roles at academic medical centers while also serving as board members for pharmaceutical companies.

A new research paper found that nearly 40 percent of drug makers worldwide – and nearly every U.S. pharmaceutical manufacturer – had at least one board member who simultaneously served in a leadership position at such centers in 2012. These included chief executives, clinical department chairs, division directors, medical school deans, hospital boards of directors and university presidents.

In its latest bid to clarify the extent to which drug makers can distribute information about unapproved uses of medicines without running afoul of the law, the FDA recently issued a draft guidance (PDF) for providing scientific journal reprints, medical textbooks and clinical practice guidelines to doctors. But the carefully crafted effort has received decidedly mixed reviews.

On one hand, the agency is being praised for trying to move the ball forward, given ongoing uncertainty over disseminating material that contains off-label uses. Although physicians may prescribe a drug as they see fit, many drug makers have been fined for promoting their medicines for uses not approved by the FDA.

Yet at the same time, the FDA is being criticized for being overly restrictive concerning some materials and for also failing to specifically address First Amendment issues that have figured prominently in some recent court rulings about drug marketing.

“The fact that they’re starting to pay attention and open up off-label communications indicates they know they have to do a better job of defending the limits they have, and specifying what can and can’t be used and how that’s done,” says John Kamp, executive director for the Coalition for Healthcare Communication, a trade group for medical publishers and advertising agencies. “There are steps forward here. But in some cases, baby steps.”

Outraged by the prices that Gilead Sciences charges for some of its medicines, an AIDS advocacy organization has succeeded in placing what is being called a unique resolution before the drug company’s shareholders. The proposal ties compensation for chief executive John Martin to wider access to the drug maker’s popular roster of HIV and hepatitis C treatments.

The shareholder resolution from the AIDS Healthcare Foundation, which has previously lambasted Gilead and other drug makers over their pricing, was proposed in response to the recently approved Sovaldi pill for hepatitis C. Gilead priced its medicine at $84,000 for a 12-week treatment, which works out to $1,000 a day. As a result, AHF maintains that Sovaldi will be unaffordable for some patients.

Such concerns, in fact, prompted the U.S. House Energy and Commerce Committee to ask Gilead to explain the rationale behind its pricing. In a letter sent yesterday to the drug maker, the lawmakers worry that Sovaldi pricing may be too high for patients with public or private insurance. A report released last week by the Institute for Clinical and Economic Review, a nonprofit that is supported, in part, by insurers, forecast that Sovaldi may negatively burden health-care budgets.

Cash may be king, but should a cash payment be used as a litmus test for whether a patent settlement between drug makers deserves anti-trust scrutiny?

A recent federal court ruling suggests the answer may be “yes.” In writing about one such deal between GlaxoSmithKline and Teva Pharmaceuticals, U.S. District Court Judge Williams Walls opined that, since there was no monetary payment involved as part of their patent settlement, there was no reason to be concerned that the arrangement was anticompetitive.

“While there may be instances in which a settlement without a monetary payment provision would raise antitrust concerns, this is not one,” Walls wrote in dismissing a challenge to a patent dispute over Glaxo’s Lamictal medication, which is used to treat epilepsy and bipolar disorder. Teva had sought to make a generic, prompting Glaxo to file a patent infringement lawsuit.

Over the past few years, the pharmaceutical industry has been embroiled in controversy over access to clinical trial data. At issue is the ability for researchers to independently verify study results and, consequently, improve patient treatments that can lead to better health and lower costs.

This sentiment has accelerated in light of various safety scandals that revealed data for some drugs was never fully published or disclosed. In response, a few drug makers – including GlaxoSmithKline and Johnson & Johnson – have recently proposed differing plans for providing access, although the extent to which their efforts will assuage concerns remains to be seen.

We spoke with Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and an associate editor at the British Medical Journal, who has been at the forefront of a campaign to prod drug makers to move faster.

The federal Department of Health and Human Services said it won’t hold the new insurance offerings available on state and federally run exchanges to the same anti-kickback standards maintained for federal health programs such as Medicare.

The decision was closely watched by the drug industry and patient advocacy groups, which worried long-standing—but controversial—programs in which drug makers help patients pay copays for costly medicines would be barred in the new health plans.

Just what was Pfizer doing with all that gold dust anyway? That’s the $750,000 question prompted by the drug maker’s recent report to police in suburban St. Louis that it couldn’t account for some gold dust at a research lab in Chesterfield, Mo. Police are investigating the missing metal, which was valued at $750,000 at the time of purchase, said Captain Steven Lewis of the Chesterfield Police Department.

Pfizer, maker of erectile-dysfunction pill Viagra and pain reliever Advil, won’t say exactly what the gold dust was for. “We use a variety of materials in the drug discovery process,” said a spokesman. “This is just one of the materials we use in our proprietary research.” The company is cooperating with the police investigation.

In the absence of more solid nuggets of information, a pharmaceutical research blogger and his readers are panning for clues about the golden mystery, offering ideas ranging from the serious to the silly. Some examples after the jump. Read More »